LOSARTAN POTASSIUM 25 Mg (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64380-933 -04

LOSARTAN POTASSIUM TABLETS USP

25 mg

30 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Strides Pharma Inc

25-30
(click image for full-size original)

NDC 64380-933 -05

LOSARTAN POTASSIUM TABLETS USP

25 mg

90 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Strides Pharma Inc

25-90
(click image for full-size original)

NDC 64380-933 -08

LOSARTAN POTASSIUM TABLETS USP

25 mg

1000 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Strides Pharma Inc

25-1000
(click image for full-size original)

NDC 64380-934 -04

LOSARTAN POTASSIUM TABLETS USP

50 mg

30 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET PROVIDED SEPARATELY

Strides Pharma Inc

50-30
(click image for full-size original)

NDC 64380-934 -05

LOSARTAN POTASSIUM TABLETS USP

50 mg

90 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Strides Pharma Inc

50-90
(click image for full-size original)

NDC 64380-934 -08

LOSARTAN POTASSIUM TABLETS USP

50 mg

1000 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Strides Pharma Inc

50-1000
(click image for full-size original)

NDC 64380-935 -04

LOSARTAN POTASSIUM TABLETS USP

100 mg

30 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Strides Pharma Inc

100-30
(click image for full-size original)

NDC 64380-935 -05

LOSARTAN POTASSIUM TABLETS USP

100 mg

90 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET PROVIDED SEPARATELY

Strides Pharma Inc

100-90
(click image for full-size original)

NDC 64380-935 -08

LOSARTAN POTASSIUM TABLETS USP

100 mg

1000 film coated tablets

Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Strides Pharma Inc

100-1000
(click image for full-size original)
LOSARTAN POTASSIUM 25 MG losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-933
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POVIDONE
PROPYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Round, Biconvex) Size 8mm
Flavor Imprint Code 11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-933-04 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-933-05 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:64380-933-08 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090382 10/09/2019
LOSARTAN POTASSIUM 50 MG losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-934
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POVIDONE
PROPYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (Round, Biconvex) Size 10mm
Flavor Imprint Code 12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-934-04 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-934-05 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:64380-934-08 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090382 10/09/2019
LOSARTAN POTASSIUM 100 MG losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-935
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
POVIDONE
PROPYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL (Oval, Biconvex) Size 18mm
Flavor Imprint Code 13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-935-04 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-935-05 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:64380-935-08 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090382 10/09/2019
Labeler — Strides Pharma Science Limited (650738743)
Registrant — Strides Pharma Global Pte. Ltd. (659220961)
Establishment
Name Address ID/FEI Operations
Vivimed Life Sciences Private Limited 860477684 ANALYSIS (64380-933), ANALYSIS (64380-934), ANALYSIS (64380-935), MANUFACTURE (64380-933), MANUFACTURE (64380-934), MANUFACTURE (64380-935), PACK (64380-933), PACK (64380-934), PACK (64380-935)

Revised: 11/2021 Strides Pharma Science Limited

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